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FDA 510(k)

CRITSPIN MICRO-HEMATOCRIT

K-Number: K920759 · 1992-04-29

ApplicantStat-Spin Technologies
Decision Date1992-04-29
Product CodeGKG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CRITSPIN MICRO-HEMATOCRIT is the device name listed in this FDA 510(k) record. The listed applicant is Stat-Spin Technologies. It received FDA 510(k) clearance on 1992-04-29 under 510(k) number K920759. The device is classified under product code GKG. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRITSPIN MICRO-HEMATOCRIT?

CRITSPIN MICRO-HEMATOCRIT is a medical device that received FDA 510(k) clearance on 1992-04-29. The listed applicant is Stat-Spin Technologies. The 510(k) number is K920759.

When did CRITSPIN MICRO-HEMATOCRIT receive FDA 510(k) clearance?

CRITSPIN MICRO-HEMATOCRIT received FDA 510(k) clearance on 1992-04-29, under 510(k) number K920759.

Who is the listed applicant for CRITSPIN MICRO-HEMATOCRIT?

The FDA 510(k) record lists Stat-Spin Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRITSPIN MICRO-HEMATOCRIT?

The FDA product code for CRITSPIN MICRO-HEMATOCRIT is GKG.

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Related Devices (Code: GKG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K961803SPUNCRIT (MODEL DRC-40)Micro Diagnostics Corp.K955795MULTI-CENTRIFUGENovonx, Inc.K930415MICROHEMATOCRIT ROTORFisher Scientific Co., LLCK925863SPUNCRITbioMerieux, Inc.K920207HERMLE Z230HLabnet Intl., Inc.K913128HEMATASTAT C-70BSeparation Technology, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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